MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, this product is to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).A follow-up will be provided when investigation conclusions are available.

Event Description

A patient called an arjo customer experience center associate representative alleging that he sustained injuries to the right cheek, right foot and other areas, when he was treated on the rotoprone bed during his stay in the icu at (b)(6).The patient claimed that he felt he was not properly rotated.The following injuries were listed: "huge soar on his right cheek so deep you can see the jaw bone actually working, his right foot torn to shreds, and other serious problems.With his foot he felt he was not properly rotated" (original description).No complaints were found reported by hospital (b)(6) between (b)(6), that would indicate any difficulties this hospital may experience using the bed.

Manufacturer Narrative

Review of rental history showed that the rotoprone bed, which was used by this patient, was delivered to this facility on (b)(6)2020 and discontinued on (b)(6) 2020.When reviewing service records and complaints related to this bed and customer, no records were found between 15 and 27 may 2020.The bed was quality control checked on (b)(6) 2020 and again post placement on (b)(6).No issues or faults were detected.Three (3) days later the bed was delivered to another facility and there was no repairs performed on the bed between those rentals.This would indicate that the bed functioned correctly and did not require a repair.In summary, the rotoprone bed was used for patient treatment, and allegedly while being on this bed, the patient sustained serious injuries.Arjo did not complete any repairs to the bed as would be customary if there were issues detected.The patient did not indicated that the rotoprone malfunctioned but stated it might not be used correctly by the facility.At this time, arjo cannot verify this allegation as it does not have enough information to do so.H3 other text : arjo was made aware of an event 2 months after the event.Bed was already rented to other facilities several times.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 10464429
• MDR Text Key: 204698336
• Report Number: 9681684-2020-00053
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention